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Resources for research hosted by UHL

In the table below, you will find a list of resources for research hosted by the University Hospitals of Leicester NHS Trust (UHL). These include Standard Operating Procedure documents (SOPs) and template forms. You can use the links in the table to access the relevant materials.

R&I ReferenceTrust ReferenceSOP Title and LinkAssociated Resources
C-2001C39/2015Informed Consent Procedure in Hosted Research in UHL Research & InnovationAppendix 1 – Blank DoA & Signature Log
C-2002BC18/2013UHL Safety Reporting for Hosted StudiesAppendix 1 – Pregnancy Notification Form

Appendix 2 – SAE Line Listing for UHL-Hosted CTIMP Studies

Appendix 3 – SAE Line Listing for UHL-Hosted Non-CTIMP Studies

Appendix 4 – Template Email Text to Request Annual SAE Line Listing for UHL-Hosted Studies

Appendix 5 – Template Email for Second Reminder Annual SAE Line Listing for UHL-Hosted Studies

Appendix 6 – Template Email Text for Final Reminder Annual SAE Line Listing for UHL-Hosted Studies

Appendix 7 – Email Request for Further Information/Clarification with Regards to Submitted SAE Line Listing

Appendix 8 – Acknowledgement Email SAE Line Listing for Hosted Studies

Appendix 9 – UHL SAE Line Listings for Hosted Studies Review Process Flowchart
C-2006B21/2023Expressions of Interest (EOI), Feasibility and Site Selection for Hosted Research at UHL
C-2013C273/2016Procedure in Event of Non-Compliance for Hosted Research in UHL
C-2014C274/2016Management & Production of CAPA for Hosted Research in UHLAppendix 1 – Corrective Action Preventative Action (CAPA) Form
C-2015C275/2016Identifying & Reporting Deviations/Serious GCP Breaches/Protocol for Hosted Research in UHLAppendix 1 – Site File Note
C-2018C278/2016End of Study Reporting Requirements for Hosted Research in UHL Research & Innovation
C-2025B52/2020UHL Pandemic Priority Expedited C&C Assessment Process
C-2028B1/2021UHL Remote Monitoring for Research Studies Hosted by UHLAppendix 1 – Remote Monitoring Risk Assessment
C-2030B53/2020Healthy Volunteers in Hosted Research in UHL Research & Innovation

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If you have any questions or issues relating to these resources, please contact us using the link at the bottom of the policies homepage.

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